Transplacental Transmission of COVID-19

Terminated

• Conditions: SARS-COV-2 Infection
• Interventions: Other: Samples concern SARS-COV-2 + pregnant women at the time of childbirth; Other: Samples concern newborns of SARS-COV-2 + mothers at birth

• Registration Number: NCT05124574
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .

The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

Detailed Description

In 2021, it becomes essential to clarify if and how SARS-COV-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of COVID-19.

SARS-COV-2, ACE2 and TMPRSS2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. From a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the Spike SARS-COV-2 protein, but also of the ACE2 receptors, TMPRSS2 and cathepsin L. Cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. Maternal leukocytes were also labeled for these proteins.

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-18
• Study Start: 2021-12-01
• Primary Completion: 2022-03-02
• Study Completion: 2022-03-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Social security affiliation
• Signed informed consent
• Pregnant woman with proven SARS-COV-2 infection during full-term delivery

Exclusion Criteria

• Patient vaccinated within 15 days prior to inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mothers infected with SARS-COV-2 at the time of delivery.	Samples concern SARS-COV-2 + pregnant women at the time of childbirth	Maternal-fetal transmission of SARS-COV-2 is likely and may require co-expression of the virus receptor (ACE2) and at least one activator of virus internalization (TMPRSS2 and/or cathepsin) in a cell to make it susceptible to SARS-COV-2 infection. To confirm these hypotheses, it is necessary to explore these mechanisms of fetal transmission in a larger number of mothers infected with SARS -CoV-2 at the time of delivery. Informed information will be given in the delivery room, initially orally by the midwives, to any mother presenting with an SARS-COV-2 infection (symptomatic or not) (whatever the variant involved). An information leaflet will also be given to the patient and consent will be systematically obtained.
mothers infected with SARS-COV-2 at the time of delivery.	Samples concern newborns of SARS-COV-2 + mothers at birth	Maternal-fetal transmission of SARS-COV-2 is likely and may require co-expression of the virus receptor (ACE2) and at least one activator of virus internalization (TMPRSS2 and/or cathepsin) in a cell to make it susceptible to SARS-COV-2 infection. To confirm these hypotheses, it is necessary to explore these mechanisms of fetal transmission in a larger number of mothers infected with SARS -CoV-2 at the time of delivery. Informed information will be given in the delivery room, initially orally by the midwives, to any mother presenting with an SARS-COV-2 infection (symptomatic or not) (whatever the variant involved). An information leaflet will also be given to the patient and consent will be systematically obtained.

Primary Outcome Measures

Name	Time	Method
Spike SARS-COV-2 protein in placental tissues	Baseline : childbirth	number of cells expressing the Spike SARS-COV-2 protein

Secondary Outcome Measures

Name	Time	Method
TMPRSS2 in placental tissues	Baseline : childbirth	number of cells expressing the TMPRSS2
cathepsin L in placental tissues	Baseline : childbirth	number of cells expressing the cathepsin L
ACE2 receptors in placental tissues	Baseline : childbirth	number of cells expressing the ACE2 receptors

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France